TOUCAN

A randomised phase II trial of carboplatin and gemcitabine +/- vandetanib in first line Treatment Of advanced Urothelial cell Cancer in patients who are not suitable to receive cisplatin.

Background

In the UK there are approximately 5,000 deaths per annum from primary urothelial tumours. The majority of these deaths are caused by locally advanced or metastatic invasive bladder cancer, which is often treated with chemotherapy. One combination of drugs that is used is carboplatin and gemcitabine. Unfortunately not everyone who receives carboplatin and gemcitabine does as well as we would like them to. There is a clinical need to improve treatment for this important subgroup of patients to whom no clinical trials are currently available. Clinical correlative and pre-clinical proof of concept data suggest that the combination of vandetanib, carboplatin and gemcitabine is worthy of clinical exploration in this group, and clinical data in other disease-settings suggest that this combination is likely to be safe.

Study design

TOUCAN is a phase II, parallel group, double-blind randomised controlled trial. Eighty-two eligible patients (i.e. with advanced urothelial cell cancer not suitable to receive cisplatin) were randomised on a 1:1 basis to receive standard gemcitabine/carboplatin chemotherapy, plus either placebo oral tablets or vandetanib tablets.

Recruitment

The original recruitment target was 122, but this figure was overestimated and amended to 82. At the end of the trial, 82 participants who were centrally randomised on a 1:1 basis received standard Gemcitabine/carboplatin chemotherapy, plus either placebo oral tablets or vandetanib tablets.

Study aim

Researchers think that adding vandetanib to carboplatin and gemcitabine may be a better treatment for this disease than carboplatin and gemcitabine alone. This study was designed to assess whether adding vandetanib is beneficial. Specifically, the study aimed at verifying whether the treatment of advanced urothelial cell cancer in patients who are not suitable to receive cisplatin can be improved by adding vandetanib. Results are currently under review.